Welchol as Monotherapy for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00789737
First received: November 10, 2008
Last updated: January 24, 2014
Last verified: January 2014
Results First Received: December 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Welchol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From January 2009 through July 2011, subjects were recruited from medical clinics, private practice and research clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

There was a 2-week placebo lead-in prior to randomization to treatment arm. Participants were excluded if two or more fasting blood glucose readings >240 mg/dL occurred during lead-in.

Subjects were excluded if there had been oral antidiabetic, significant insulin, or bile acid sequestrant therapy in the 3 months prior to screening.


Reporting Groups
  Description
Welchol

Welchol 625mg tablets

Welchol : Welchol 625mg tablets

Placebo

placebo

Placebo : placebo


Participant Flow:   Overall Study
    Welchol     Placebo  
STARTED     176     181  
COMPLETED     128     126  
NOT COMPLETED     48     55  
Withdrawal by Subject                 13                 22  
Lost to Follow-up                 10                 14  
Adverse Event                 8                 8  
Protocol Violation                 3                 0  
Lack of Efficacy                 3                 0  
hyperglycemia that met protocol-specifie                 0                 4  
not specified                 11                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Welchol

Welchol 625mg tablets

Welchol : Welchol 625mg tablets

Placebo

placebo

Placebo : placebo

Total Total of all reporting groups

Baseline Measures
    Welchol     Placebo     Total  
Number of Participants  
[units: participants]
  176     181     357  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     165     167     332  
>=65 years     11     14     25  
Age  
[units: years]
Mean ± Standard Deviation
  52.6  ± 10.25     51.8  ± 10.52     52.2  ± 10.38  
Gender  
[units: participants]
     
Female     82     92     174  
Male     94     89     183  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     86     80     166  
Not Hispanic or Latino     90     101     191  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     12     11     23  
Asian     12     8     20  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     27     29     56  
White     122     131     253  
More than one race     0     0     0  
Unknown or Not Reported     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     176     181     357  
Body mass index  
[units: kg/m*2]
Mean ± Standard Deviation
  32.0  ± 6.5     31.8  ± 4.94     31.9  ± 5.75  
baseline body mass index category [1]
[units: participants]
     
<30 kg/m*2     68     66     134  
>= 30 kg/m*2     108     115     223  
Duration of type 2 diabetes  
[units: years]
Mean ± Standard Deviation
  4.3  ± 4.69     3.9  ± 4.39     4.1  ± 4.54  
[1] number >= 30 kg/m*2 and number <30 kg/m*2



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Hemoglobin A1c   [ Time Frame: 24 week ]

2.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: from baseline to 24 weeks ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Change in Fasting Plasma Glucose
Measure Description to determine changes in Glycemic control after 24 weeks on therapy
Time Frame from baseline to 24 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Some participants may not have had lab results for this specific analysis and therefore excluded.

Reporting Groups
  Description
Welchol

Welchol 625mg tablets

Welchol : Welchol 625mg tablets

Placebo

placebo

Placebo : placebo


Measured Values
    Welchol     Placebo  
Number of Participants Analyzed  
[units: participants]
  172     166  
Change in Fasting Plasma Glucose  
[units: mg/dL]
Least Squares Mean ± Standard Error
  -4.6  ± 3.45     5.7  ± 3.51  


Statistical Analysis 1 for Change in Fasting Plasma Glucose
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0373
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units   [ Time Frame: 24 weeks ]

4.  Secondary:   % Subjects Achieving an HbA1C Goal of <7.0   [ Time Frame: 24 weeks ]

5.  Secondary:   % Subjects With a Decrease in FPG >=30 mg/dL   [ Time Frame: from baseline to 24 weeks ]

6.  Secondary:   Changes in Total Cholesterol [TC]   [ Time Frame: from baseline to 24 weeks ]

7.  Secondary:   Changes in Low Density Lipoprotein Cholesterol [LDL-C]   [ Time Frame: from baseline to 24 weeks ]

8.  Secondary:   Changes in High Density Lipoprotein Cholesterol [HDL-C]   [ Time Frame: from baseline to 24 weeks ]

9.  Secondary:   Changes in Non-HDL-C   [ Time Frame: from baseline to 24 weeks ]

10.  Secondary:   Changes in Triglycerides [TG]   [ Time Frame: from baseline to 24 weeks ]

11.  Secondary:   Changes in Apolipoprotein A-I (apoA-I)   [ Time Frame: from baseline to 24 weeks ]

12.  Secondary:   Changes in Apolipoprotein B (apoB)   [ Time Frame: from baseline to 24 weeks ]

13.  Secondary:   Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test   [ Time Frame: from baseline to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director Metabolic Clinical Development
Organization: Daiichi Sankyo Pharma Development
phone: 732-590-5000


No publications provided


Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00789737     History of Changes
Other Study ID Numbers: WEL-305
Study First Received: November 10, 2008
Results First Received: December 4, 2013
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration